Testing LLX-424 for patients with kidney stones
A Phase 2a Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamic (PD) Effects of LLX-424 in Patients With a History of Kidney Stones
PHASE2 · Lilac Therapeutics, Inc. · NCT06932146
This study is testing a new medication called LLX-424 to see if it can help people who have had kidney stones feel better and prevent future stones.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Lilac Therapeutics, Inc. (industry) |
| Locations | 3 sites (Saint Paul, Minnesota and 2 other locations) |
| Trial ID | NCT06932146 on ClinicalTrials.gov |
What this trial studies
This Phase 2a study evaluates the safety and effectiveness of LLX-424, a glycolate oxidase inhibitor, in patients who have a history of kidney stones. Participants will be randomly assigned to receive either LLX-424 or a placebo for a duration of 8 weeks. The study aims to assess pharmacokinetics, pharmacodynamics, and overall tolerability of the drug. Follow-up visits will occur to monitor safety and health outcomes after treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals with a documented history of calcium oxalate kidney stones and stable kidney function.
Not a fit: Patients with kidney stones of a type other than calcium oxalate or those with unstable kidney function may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence of kidney stones in affected patients.
How similar studies have performed: While this approach is novel, similar studies targeting kidney stone prevention have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of kidney stones documented in medical records * 24-hour urine oxalate excretion * Body mass index 18.5 to 38 kg/m2 inclusive * Estimated glomerular filtration rate ≥ 60 mL/min/1.73m2 Exclusion Criteria: * History or medical record evidence of kidney stones that are not calcium oxalate * Unstable kidney function * Spot urine protein to creatinine ratio ≥ 1 mg/mg at screening * History of kidney transplantation * Hemoglobin A1c \> 9.5% at screening * History of enteric hyperoxaluria, intestinal malabsorption, bariatric surgery, intestinal surgery, inflammatory bowel disease * History or evidence of cirrhosis
Where this trial is running
Saint Paul, Minnesota and 2 other locations
- Clinical Research Site #2 — Saint Paul, Minnesota, United States (RECRUITING)
- Clinical Research Site #3 — Springfield, Missouri, United States (RECRUITING)
- Clinical Research Site #1 — San Antonio, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Clinical Operations
- Email: lilacct@lilactx.com
- Phone: 925-974-3301
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kidney Stones, oxalate, glycolate oxidase